An interventional study of Body Weight Support Gait Training and Traditional Gait Training in CVA (Cerebrovascular Accident) and Stroke, sponsored by Florida Gulf Coast University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Florida Gulf Coast University · Not applicable, Interventional, and Treatment
Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.
Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.
The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).
Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.
The procedure for gait analysis is as follows:
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Florida Gulf Coast University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The Traditional Gait Training group will receive gait training as presently performed without additional modalities.
Other: Traditional Gait Training
The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.
Device: Body Weight Support Gait Training
Also known as: BSWTT, LiteGait
Also known as: Overground
Gait Speed
Velocity of center of mass of the participant.
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Length
Difference in position between the feet at heel strike, in the direction of forward motion.
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Width
Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Step Asymmetry
The ratio of the difference of left and right step length over the stride length.
Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Gait Units
Measure of the quantity of therapy received during the duration of care.
Time frame: Measured at discharge, approximately 21 days
Functional Independence Measure (FIM)
A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.
Time frame: Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
Length of Stay
Total duration of care at the acute rehabilitation facility.
Time frame: Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.
No study locations are listed for this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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